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Improving Access To Medicines Doesn't Have To Mean More Patents, Luigi Palombi
Improving Access To Medicines Doesn't Have To Mean More Patents, Luigi Palombi
Luigi Palombi
Access to medicines presupposes that there are medicines to access, but the development of medicines, especially those needed to treat diseases that inflict the poor and the disadvantaged, are especially difficult to access because of the pharmaceutical industry’s paradigm of medicines being inextricably linked to patents; meaning, without patents there is no incentive to undertake the necessary R&D to develop new medicines. This paper argues that this is a lie; told by pharmaceutical executives and spread by well meaning scientists. Uncontested by policymakers in the 1960’s it has become a truth that threatens scientific progress, the development of appropriate medicines …
Fda New Drug Review Times, Prescription Drug User Fee Acts, And R&D Spending, John Vernon
Fda New Drug Review Times, Prescription Drug User Fee Acts, And R&D Spending, John Vernon
John Vernon
FDA approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical R&D have likely increased. In the current paper we employ a unique survey dataset, one which includes data from 1990 to 1999 on firm-level pharmaceutical R&D expenditures for 7 large, U.S.-based drug companies. We estimate the effect FDA approval times have on firm R&D spending. Controlling for other factors such as pharmaceutical profitability and cash flows, we estimate that a 10 percent decrease (increase) in FDA approval times leads to an increase …
Regulatory Data Protection Under Trips Article 39(3) And Article 10bis Of The Paris Convention: Is There A Doctor In The House?, Christopher Wadlow
Regulatory Data Protection Under Trips Article 39(3) And Article 10bis Of The Paris Convention: Is There A Doctor In The House?, Christopher Wadlow
Christopher Wadlow
Article 39 of the WTO TRIPs Agreement has attracted much attention for the protection its final paragraph affords for regulatory data in the pharmaceutical and agrochemical industries, but the literature has tended to treat Article 39(3) in individual isolation. This is to ignore one of the most striking features of Article 39, which is that in contrast to every other substantive provision of TRIPs, it expressly defines its entire scope of application by reference to a pre-existing treaty, the Paris Convention for the Protection of Industrial Property, and specifically Article 10bis of the latter, dealing with unfair competition. This article …